Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-5015
FDA device recall Z-2069-2025 · posted 2025-07-02 · Open, Classified
Recall details
- Recalling firm
- CORIN MEDICAL, LTD.
- Reason for recall
- Investigation has identified that the age of the nylon packaging material has caused a loss of integrity of some pouches.
- Action taken
- Corin Group notified US agents informally via email on 05/23/2025 and informed them of an investigation and affected inventory to quarantine. A formal notification was sent to consignees on about 06/02/2025. Consignees were instructed to identify any affected units on hand and quarantine them, return them to Corin and notify all affected parties who handled the product. Consignees were also requested to complete and return the acknowledgement form. If product was further distributed, Corin requested contact information to contact those customers.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- JWH
- Quantity affected
- 341 units
- Distribution
- US Nationwide distribution in the states of CA, CO, FL, IL, OK, TX, UT.
- Date initiated
- 2025-05-23
- Date posted
- 2025-07-02
- Location
- Cirencester, United Kingdom
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Apex Revision Knee System (K153437) | Omnilife Science | 2015-12-21 |
| APEX REVISION KNEE SYSTEMS (K112891) | Omni Life Science, Inc. | 2012-02-29 |
| APEX KNEE MODULAR TIBIA SYSTEM (K101994) | Omnlife Science | 2010-09-28 |